NCT00062257

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2003

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 15, 2013

Status Verified

March 1, 2005

First QC Date

June 5, 2003

Last Update Submit

May 14, 2013

Conditions

Gastric Cancer

Keywords

recurrent gastric cancerstage IV gastric canceradenocarcinoma of the stomach

Interventions

irofulvenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed gastric adenocarcinoma * Recurrent or metastatic disease * Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction * Measurable disease * At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active disseminated intravascular coagulation Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases) * Alkaline phosphatase no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No other uncontrolled concurrent illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Must have central or peripherally inserted central catheter PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa Chemotherapy * No prior chemotherapy for recurrent or metastatic disease * Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational or commercial agents or therapies for the malignancy * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Cancer Institute at National University Hospital

Singapore, 119074, Singapore

Location

Johns Hopkins - Singapore

Singapore, 119074, Singapore

Location

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

irofulven

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Winnie Yeo

    Prince of Wales Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

June 1, 2003

Study Completion

September 1, 2006

Last Updated

May 15, 2013

Record last verified: 2005-03

Locations

AU(1)KR(1)HK(1)SG(3)